Electrode device for continuous ECG monitoring
The electrode device with adjustable straps and perforations, combined with reusable electrodes, addresses ECG signal distortion and discomfort by ensuring secure, versatile, and comfortable long-term monitoring across diverse body types.
Patent Information
- Authority / Receiving Office
- RU · RU
- Patent Type
- Patents
- Current Assignee / Owner
- OBSHCHESTVO S OGRANICHENNOJ OTVETSTVENNOSTYU BIEN-TEKH
- Filing Date
- 2025-08-06
- Publication Date
- 2026-07-02
Smart Images
Figure 00000001_ABST
Abstract
Description
[0001] The invention relates to medical equipment and can be used for continuous collection of information about the functional state of a person during electrocardiography studies.
[0002] Various designs of skin electrodes are known in electrocardiographic (ECG) monitoring systems to ensure electrical contact with the patient's body, and at the same time not to cause discomfort in a wearable version.
[0003] The problems of long-term ECG monitoring are:
[0004] - ECG signal recording artifacts that occur when reusable electrodes rub against the human body during human movements, which leads to distortion of the ECG signal;
[0005] - displacement of electrodes from the correct positions of ECG leads during human movement, which leads to incorrect interpretation of the registration results;
[0006] - poor contact of the electrodes with human skin, up to detachment, due to the appearance of sweat and sebum secretions;
[0007] - discomfort in the patient’s daily life due to the need to constantly wear the electrode device.
[0008] The problem of ensuring good quality contact between the electrode and human skin is solved by using belts and corsets made of elastic materials that press the electrodes to the human body.
[0009] For example, the publication [US 6205346 B1, "Electrodes apron for ECG", Akiva Sharon et al., March 20, 2001] describes a headset in the form of a silicone belt with built-in electrodes, which encircles the chest and is secured to the upper arm and forearm. The stretchable elastic belt ensures placement of the electrodes in the desired areas and ensures high-quality contact. However, this known solution is not intended for long-term wear.
[0010] A known design of an electrode system for a wearable ECG monitor is described in the publication [EP 1946698 A2, "Medizinische Trageeinrichtung", Huebner Tomas et al., July 23, 2008]. It comprises an over-the-head device with shoulder straps and a waist portion made in the form of a textile belt, to which the wearable monitor device is attached. Electrodes for recording ECG signals are placed under the shoulder straps and on the waist portion, and the wires connecting the electrodes are routed inside the straps. Several elements of the design are made of elastic material to compensate for body movement. However, this design does not provide for proper electrode placement and does not address the problem of artifacts arising from human movement.
[0011] Invention [RU 2444988 C1 “Electrode device for a wearable ECG monitor”, Bonch-Bruevich V.V., Filatov A.L., 20.03.2012.] “Electrode device for a wearable ECG monitor” contains a system of skin electrodes and a monitoring unit, electrically connected to each other and placed on a suspension attached to the body.
[0012] The device is characterized by its skin electrode system comprising matrices of pin electrodes, the free ends of which have a convex spherical surface and are mounted on a waist-mounted suspension system that fits the torso, providing dry galvanic contact with the anterior chest area during the patient's natural movements. The end fastening portions of the electrode pins are secured to a flexible dielectric base connected to the suspension system, which is made of elastic textile material.
[0013] The pendant is made of elastic bands, has a back fastener and adjustable straps that interact with the possibility of easy connection / disconnection.
[0014] The advantages of the known solution are:
[0015] - increasing the reliability of the galvanic contact between the patient's body and the monitor's dry electrode system, i.e., contact that does not use conductive gels, by providing variability with a large number of identical contacts, which reduces motion artifacts during long-term use.
[0016] - the ability to put on the electrode device independently.
[0017] The disadvantages of the known solution are:
[0018] - registration of only one ECG lead instead of three standard ones for ECG monitoring;
[0019] - large size of electrode matrices, which makes it impossible to register standard ECG leads with precisely defined ECG signal registration points;
[0020] - using the back fastener is inconvenient for many categories of patients (elderly people, disabled people).
[0021] The closest publication to the claimed solution is [Yadav, B.S. & Vishwakarma, R.K. (2020) Wearable and chest size-adjusted 12-lead electrode array system to record electrocardiogram: A novel design. Natl J Physiol Pharm Pharmacol, 10 (2), 173-176. doi:10.5455 / njppp.2020.10.1238222122019] - a prototype. The known solution proposes an electrode device consisting of shoulder straps that are adjustable in size and a belt, also adjustable in size to fit a specific patient. Wires are built into the straps and belt, on one end of which standard clips are installed for connecting skin electrodes with a push-button connector. All wires are connected to the monitoring unit at the other end.
[0022] The authors of the well-known solution proposed a universal solution for placing electrodes in specific positions on the patient's body based on the processing of statistical data on the chest anthropometry of 250 patients.
[0023] The advantages of the prototype are:
[0024] the ability to use a single size electrode device for patients with different constitutions;
[0025] - the ability to put on the electrode device independently using the back fastener;
[0026] - the ability to use standard electrodes with a push-button connector.
[0027] The disadvantages of the prototype are:
[0028] - the dimensions of the electrode device and the electrode connection points are calculated for patients with a small variation in chest sizes (92.07±8.02 cm), which does not allow the proposed solution to be used for patients of different constitutions;
[0029] - it is obvious that the electrode device is intended to use standard disposable ECG electrodes, which leads to deterioration of electrical contact with human skin during long-term monitoring;
[0030] - Using the back fastener is inconvenient for many categories of patients.
[0031] The objective of the invention is to create a patient-friendly electrode device for recording ECG, ensuring the quality of ECG signal recording, versatility of use and long-term monitoring under the conditions of the patient's daily life.
[0032] The technical result of the invention is an electrode device with increased functionality and reliability of ECG signal recording.
[0033] The stated task is achieved in that the electrode device contains a monitoring unit, shoulder straps and a belt made of elastic material with the ability to adjust the size, wires between the monitoring unit and the ECG electrode connectors passing inside the shoulder straps and belt, according to the claimed technical solution, the shoulder straps and belt of the device are made with perforation in the places of the ECG leads, the belt is made with fixation in the front, and the device additionally contains reusable ECG electrodes consisting of a central part made of metal with high electrical conductivity and an Ag / AgCl coating on the area of contact of the electrode with the patient's skin, an elongated tail with a push-button connector, and a rim part made of elastic silicone.
[0034] The essence of the invention is explained by the drawings Fig. 1, Fig. 2 and Fig. 3.
[0035] Fig. 1 shows an example of placement of the electrode device on the patient, left is the front view, right is the back view.
[0036] Fig. 2 shows a variant of manufacturing and dimensions of perforation.
[0037] Fig. 3 shows a view of a reusable electrode.
[0038] In accordance with Fig. 1, the electrode device consists of a monitoring unit 1 with a patient cable 2 equipped with standard push-button clips 3 for connection to any electrodes having a standard push-button connector, shoulder straps 4 and a belt 5.
[0039] Shoulder straps 4 and belt 5 are made of elastic material to ensure reliable pressure of the electrodes to the patient's body during movement. Shoulder straps 4 and belt 5 are adjustable in length to fit a specific patient and can be subsequently secured by any known method (e.g., with Velcro fastener 6). Belt 5 is designed to be secured by any known method (e.g., with Velcro fastener 6) at the front of the patient's body. Shoulder straps 4 and belt 5 are designed to secure the wires of patient cable 2 to them (e.g., they are made of a multilayer material to allow the wires to pass between the layers of material, or they can be secured with sewn-on loops or pieces of Velcro).
[0040] Monitoring unit 1 is secured to belt 5 in any known manner (e.g., placed in a pocket). The wires of patient cable 2 are secured to shoulder straps 4 and belt 5. Push-button clips 3 are located on the outer side of shoulder straps 4 and belt 5. Reusable electrodes 10 (shown by the dashed line in Fig. 1) are installed on the patient's body on the inner side of shoulder straps 4 and belt 5.
[0041] The shoulder straps 4 and the belt 5 are equipped with perforation holes 7 (not shown in Fig. 1) at the places where the reusable electrodes 10 are applied. The perforation holes 7 (a possible arrangement of the perforation holes is shown in Fig. 2) have a diameter of 4...5 mm, which is necessary for the passage of the button connector 12 of the ECG electrode. The perforation holes 7 are made in such a number and with such a distance between them as to ensure a deviation in the position of the shoulder straps 4 or the belt 5 relative to the place where the reusable electrodes 10 (ECG leads) are applied within a few centimeters. Such a deviation makes it possible to reduce the range of standard sizes of the electrode device for patients of different constitutions, while maintaining the correct application of the ECG electrodes.
[0042] According to Fig. 3, the reusable electrode 10 consists of a central part 11 with a button connector 12 and a contact pad 13, and a rim part 14.
[0043] The central part 11 is made of metal with high electrical conductivity.
[0044] Push-button connector 12 is designed to accept a standard push-button clip 3 for attaching ECG electrodes. The length of push-button connector 12 is determined by the thickness of the material of the shoulder straps 4 or belt 5 through which the tail of push-button connector 12 is threaded, and the depth at which push-button clip 3 snaps into place.
[0045] The contact pad 13 is made on the central part 11 from the Ag / AgCl alloy by any known method (for example, by galvanic method or plasma spraying).
[0046] The rim part 14 is made of hypoallergenic medical elastic silicone by any known method (for example, casting).
[0047] Reusable electrode 10 is applied to patient's body at certain points (ECG leads) and pressed from above by elastic elements (shoulder straps 4 or belt 5) of the electrode device. Push-button connector 12 of reusable electrode 10 passes through one of perforation holes 6 of shoulder straps 4 or belt 5 and is fixed by push-button clip 3 of patient cable 2. Contact pad 13 comes into contact with patient's skin and transmits electrocardiographic signal from ECG lead through central part 11 to push-button connector 12 and further through push-button clip 3 of patient cable 2 to monitoring unit 1. Rim part 14 of reusable electrode 10 due to elasticity and high adhesion of silicone to skin fits tightly to human body, preventing reusable electrode 10 from shifting during patient's movements.
[0048] The possibility of applying and fixing the reusable electrode 10 at the correct points of the ECG leads is determined by the perforation (a row of holes) of the shoulder straps 4 and the belt 5 of the electrode device, which makes it possible to fix the reusable electrode 10 with deviations to the right-left and up-down up to several centimeters relative to the position of the shoulder straps 4 and the belt 5 on the patient's body.
[0049] The electrode device is operated as follows.
[0050] Option No. 1 - personal use by one patient.
[0051] In Option 1, the electrode device is adjusted with the participation of medical personnel. During the first use, the patient puts on the electrode device and adjusts its size, fixing the length of the shoulder straps 4 and belt 5 with fasteners 6. Next, the medical personnel apply reusable electrodes 10 to the patient's body under the shoulder straps 4 and belt 5 in accordance with the selected ECG lead system, while all reusable electrodes 10 are fixed on the electrode device by passing the push-button connectors 12 of the reusable electrodes 10 through the perforations 7 on the shoulder straps 4 and belt 5. The selected perforation holes 7 are marked in any known manner (e.g., with stickers) for future independent use of the electrode device by the patient. Next, the clips 3 of the patient cable 2, connected to the monitoring unit 1, are snapped onto the push-button connectors 12. The electrode device is ready to record an ECG, and the monitoring unit 1 is turned on.
[0052] During long-term ECG recording, the patient can remove and insert the electrode device. Correct placement of the reusable electrodes 10 during insertion is ensured by initially setting up and fixing the electrode device configuration for the specific patient.
[0053] To sanitize the electrode device, the reusable electrodes 10 are unfastened from the push-button clips 3 of the patient cable 2, and the monitoring unit 1 is separated from the belt 5. After sanitizing the electrode device, the monitoring unit 1 is secured to the belt 5, the reusable electrodes 10 are installed in the marked perforation holes on the shoulder straps 4 and the belt 5 and are snapped into place with the clips 3 of the patient cable 2.
[0054] Option No. 2 - use of the electrode device in medical and preventive institutions on many patients (for example, when conducting functional tests).
[0055] In Option #2, the patient dons the electrode device and adjusts it to size, recording the length of the shoulder straps and belt. Next, medical personnel apply all reusable electrodes 10 in accordance with the selected ECG lead system. All reusable electrodes 10 are secured to the electrode device by passing push-button connectors 12 through perforations 6 on shoulder straps 4 and belt 5. Clips 3 of patient cable 2, connected to monitoring unit 1, snap onto push-button connectors 12. The electrode device is ready for ECG recording, and monitoring unit 1 is turned on.
[0056] After the ECG recording procedure is completed, the electrode device is sanitized for use by the next patient. To do this, the reusable electrodes 10 are unfastened from the push-button clips 3 of the patient cable 2, and the monitoring unit 1 is separated from the belt 5.
[0057] The claimed technical result of the invention, which consists in increasing the convenience, functionality and reliability of recording the ECG signal of the electrode device, is achieved through a combination of design solutions and consists of the following:
[0058] 1. The proposed electrode device allows patients to remove it during ECG recording and then put it on independently. The front-facing position of the electrode device's 6 fasteners allows it to be used by patients of varying physical abilities.
[0059] 2. The versatility of the proposed electrode device in terms of use by patients of different constitutions is achieved through the perforation of 7 shoulder straps 4 and belt 5. This allows the use of the same electrode device for patients of different constitutions by rearranging the reusable electrodes 10 to the desired position.
[0060] The versatility of the proposed electrode device from the point of view of using other monitoring units 1 consists in the fact that the reusable electrode 10 is equipped with a standard push-button connector 12 and, accordingly, it is possible to connect to it any cardiac monitors equipped with a patient cable 2 with standard push-button clips 3.
[0061] The versatility of the proposed electrode device in terms of application options is that the electrode device can be used both by the patient independently and under the supervision of medical personnel in medical and preventive institutions to record the ECG signal during patient movement during functional tests.
[0062] The versatility of the proposed electrode device from the point of view of recording ECG in various ECG lead systems is achieved by changing the number and positions of the reusable electrodes 10 on the shoulder straps 4 and the belt 5. For example, in accordance with Fig. 1, the reusable electrodes located on the shoulder straps 4 can be used as electrodes RA and LA of a standard monitor lead system, while the electrodes RL and LL are the reusable electrodes 10 located on the belt 5 along the axillary lines (far right and left in Fig. 1). By adjusting the position of the middle of belt 5 between the 4th and 5th intercostal spaces, it is possible to record an ECG using the modified EASI ECG lead system [RU 168748 U1 “Device for cardiac monitoring”, Klypin D.N., 02 / 17 / 2017].
[0063] 3. The reliability of ECG signal recording by the proposed electrode device is achieved through the use of reusable electrodes (10) with a rim (14) made of elastic silicone. Strong adhesion of the silicone to the patient's skin prevents the reusable electrode (10) from shifting during patient movement. At the same time, due to the biocompatibility of silicone with human skin, allergic reactions do not occur during long-term ECG signal recording.
Claims
An electrode device for continuous ECG monitoring, comprising a monitoring unit, shoulder straps and a belt made of elastic material with the ability to adjust in size, wires between the monitoring unit and the connectors of the ECG electrodes, passing inside the straps and belt, characterized in that the shoulder straps and belt of the device are made with perforation in the places of the ECG leads, the shoulder straps and belt are made with fixation in the front, and the device additionally contains reusable ECG electrodes consisting of a central part made of metal with high electrical conductivity and an Ag / AgCl coating at the contact area of the electrode with the patient's skin, an elongated tail with a push-button connector and a rim part made of elastic silicone, wherein the monitoring unit is fixed on the belt, and the wires of the patient cable connected to it, which is equipped with push-button clips for connection to the electrodes, are fixed on the shoulder straps and belt,The push-button clips are located on the outside of the shoulder straps and belt, and the electrodes are designed to be installed on the inside of the shoulder straps and belt, the perforation holes are made in such a quantity and with such a distance between them as to ensure a deviation in the position of the shoulder straps or belt relative to the place of application of the electrodes, the length of the push-button connector is determined by the thickness of the material of the shoulder straps or belt through which the tail of the push-button connector is threaded, and the depth of snapping of the push-button clip.